Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087)

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02453594

Collaborator

(none)

211

Enrollment

Arms

89.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a study of pembrolizumab (MK-3475) for participants with relapsed/refractory classical Hodgkin Lymphoma (RRcHL) who: 1) have failed to achieve a response or progressed after autologous stem cell transplant (auto-SCT) and have relapsed after treatment with or failed to respond to brentuximab vedotin (BV) post auto-SCT or 2) were unable to achieve a Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV or 3) have failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT.

The primary study hypothesis is that treatment with single agent pembrolizumab will result in a clinically meaningful overall response rate.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma	Biological: pembrolizumab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

211 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Clinical Trial of MK-3475 (Pembrolizumab) in Subjects With Relapsed or Refractory (R/R) Classical Hodgkin Lymphoma (cHL)

Actual Study Start Date :

Jun 10, 2015

Anticipated Primary Completion Date :

Nov 11, 2022

Anticipated Study Completion Date :

Nov 11, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle for up to 24 months.	Biological: pembrolizumab IV infusion Other Names: MK-3475 KEYTRUDA®
Experimental: Cohort 2 Participants with RRcHL who were unable to achieve CR or PR to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle for up to 24 months.	Biological: pembrolizumab IV infusion Other Names: MK-3475 KEYTRUDA®
Experimental: Cohort 3 Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.	Biological: pembrolizumab IV infusion Other Names: MK-3475 KEYTRUDA®

Arm

Intervention/Treatment

Experimental: Cohort 1

Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle for up to 24 months.

Biological: pembrolizumab

IV infusion

Other Names:

MK-3475

KEYTRUDA®

Experimental: Cohort 2

Participants with RRcHL who were unable to achieve CR or PR to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle for up to 24 months.

Biological: pembrolizumab

IV infusion

Other Names:

MK-3475

KEYTRUDA®

Experimental: Cohort 3

Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.

Biological: pembrolizumab

IV infusion

Other Names:

MK-3475

KEYTRUDA®

Outcome Measures

Primary Outcome Measures

Overall Response Rate (ORR) [Up to 35 months]
Percentage of Participants Experiencing at Least One Adverse Event (AE) [Up to 27 months]
Percentage of Participants Discontinuing Study Drug Due to AEs [Up to 24 months]

Secondary Outcome Measures

Complete Remission Rate (CRR) [Up to 35 months]
Progression-free Survival (PFS) [Up to 35 months]
Duration of Response (DOR) [Up to 35 months]
Overall Survival (OS) [Up to 35 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Relapsed or refractory de novo classical Hodgkin lymphoma
Participant may have failed to achieve a response to, progressed after, or be ineligible for autologous stem cell transplant (auto-SCT)
Participant may have failed to achieve a response or progressed after treatment with brentuximab vedotin or may be brentuximab vedotin naïve
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Measurable disease
Adequate organ function

Exclusion criteria:

Diagnosis of immunosuppression or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
Prior monoclonal antibody within 4 weeks prior to study Day 1 or chemotherapy, targeted small molecular therapy, or radiation therapy within 2 weeks prior to study Day 1
Prior allogeneic hematopoietic stem cell transplantation
Known clinically active central nervous system involvement
Known additional malignancy that is progressing or requires active treatment
Has a known history of Human Immunodeficiency Virus (HIV)
Has known active Hepatitis B (HBV) or Hepatitis C (HCV)
Active autoimmune disease requiring systemic treatment in past 2 years
Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis